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Head of Clinical Development and Medical Affairs

Edison, NJ

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Our client is seeking a Head of Clinical Development & Medical Affairs near Brunswick, NJ!

Our client is a diagnostics company in the therapeutic area of oncology. Their vision is to develop breakthrough cancer therapies/treatments from early to late stages including early detection, loco-regional therapy, prognostic tests, and systemic treatments. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This role allows for upward mobility in the future, provides regular training, and promotes a teamwork-driven environment. The two primary functions of this position are implementing strategy in terms of drug development as well as acting as the face of the company for all medical affairs activities. This role will provide their recommendations on all aspects of clinical study development including the following: regulatory affairs instances, enrolling patients for the studies, overseeing safety standards, developing biomarkers, analyzing and using data, writing/submitting manuscripts, and presenting the data at meetings to important key figures.

Specific Responsibilities:

  • Assist with the planning of clinical advancement systems (policies/procedures) while incorporating the company’s oncology program
  • Support the company’s oncology program through designing the clinical studies, developing biomarkers, and carrying out the first three phases of the different studies
  • Act as the lead scientific monitor and the representee to the sponsor for different vendors, CRO’s, PI’s and laboratories involved in the studies
  • Manage all of the regulatory elements throughout the clinical development process including protocols, safety standards, IND’s, CTA’s, brochures, CRF’s, CSR’s, ISS’s, ISE’s, and clinical expert summaries
  • Responsible for analyzing the data of the clinical studies, including monitoring safety standards, and implementing corrective actions when necessary
  • Choose the location of the site and the review of any clinical studies brought on by an investigator and provide guidance at meetings
  • Create relationships with industry thought leaders, relevant experts, key partners in the industry, academia, and in the political arenas to better the company’s reputation
  • Develop publications, execute manuscripts/reports, and give presentations both nationally/internationally

Qualifications:

  • Must be a board-certified M.D. with an oncology specialist accreditation
  • Range of 2-7+ years in clinical development, medical affairs, and immunology
  • Heavy industry experience with clinical trials; background in biopharma is preferred
  • Very strong understanding of early clinical phases of developing drugs
  • Need experience with regulatory documentation and with governing bodies (FDA/EMA)
  • Self-starter that can meet deadlines and is proficient with computer software